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A PPP managed by FNIH Partners are NIH, FDA, CMS, and private industry Barbara B. Mittleman, M.D. Director, NIH PPP Pro

Public Private Partnerships at the NIH; The Biomarkers Consortium (BC). A PPP managed by FNIH Partners are NIH, FDA, CMS, and private industry Barbara B. Mittleman, M.D. Director, NIH PPP Program Bioinformatics Forum March 4, 2009. BC Mission.

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A PPP managed by FNIH Partners are NIH, FDA, CMS, and private industry Barbara B. Mittleman, M.D. Director, NIH PPP Pro

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  1. Public Private Partnerships at the NIH; The Biomarkers Consortium (BC) A PPP managed by FNIHPartners are NIH, FDA, CMS, and private industry Barbara B. Mittleman, M.D. Director, NIH PPP Program Bioinformatics Forum March 4, 2009

  2. BC Mission • The Biomarkers Consortium endeavors to discover, develop, and qualify biological markers (biomarkers) to support new drug development, preventive medicine, and medical diagnostics.  • Precompetitive Consortium

  3. Biomarkers Consortium Partners • Public • NIH • FDA • CMS • Private • PhRMA / BIO • Industry/ individual companies • Non-Profit • Patient Advocacy Groups and Professional Societies • Universities • FNIH

  4. FNIH • FNIH : • 501(c)(3) charitable foundation • i.e., NOT the government! • Chartered by Congress in 1990 • Incorporated in 1996 • Mission, per Congress, is to support the mission of the NIH • Managing partner of the BC

  5. BC Structure

  6. Governance Structure • Executive Committee (15 members) • decision-making: advise FNIH Board on financial commitments • 3 NIH, 3 FDA, 3 pharmaceutical industry, 1 CMS, 1 biotech/diagnostics/imaging industry, 1 public, 3 (non-voting) FNIH • Steering Committees • Content area focused : Neuroscience, Metabolic Diseases, Oncology, Inflammation and Immunity • Identify and oversee specific project activities • Project Teams • Implement projects

  7. Intellectual Property • Pre-competitive focus: BC strives not to generate new IP, although it might happen • Existing IP coming into PPPs will be protected • New IP will be handled in accordance with Federal law and BC/PT specific agreements

  8. Data/Sample Sharing and Access • Must comply with human subjects protections • Informed consents must be consistent with the BC activities if samples are to be used or distributed • Precompetitive structure broad public availability of data and samples, generation of public resources

  9. Confidentiality • Pre-existing data, samples, and activities contributed to BC activities will be considered to be confidential if the donor requests (subject to antitrust review) • Confidentiality Agreements will be executed, as needed • No more than the minimum needed for Consortium activities should be shared with project • Aim is to maximize public availability, in accordance with the project plan

  10. Conflict of Interest • FNIH is not NIH • For NIH employees, these are official duty activities • FNIH rules require disclosure and reporting • Intention is to optimize fairness and openness.

  11. Antitrust Issues • Industry collaborations with more than a single company may expose participants to antitrust liability • The Federal government is not liable • Partnering with the government does not immunize private partners against antitrust liability • BC rules comply with Federal antitrust law

  12. BC Grantee/Contractor Selection • FNIH is not NIH • Awards are FNIH awards, not NIH awards • FNIH/BC Conflict of Interest and Confidentiality policies apply • Solicitation and independent scientific review conducted by FNIH • Responders, awardees, and reviewers may be BC members or not

  13. Initial Projects 1) FDG-PET: qualification studies Lymphoma non-small cell lung cancer 2) Adiponectin in Type 2 Diabetes data pooling to assess utility of adiponectin as a marker of PPAR against responsiveness

  14. Initial Projects 3) PET ligand development: developing and qualifying PET tools for drug development 4) Circulating Tumor Cell identification 5) Other projects in development in OA, depression, etc….

  15. Important Links • NIH PPP Program http://ppp.od.nih.gov • FNIH www.fnih.org • The Biomarkers Consortium www.biomarkersconsortium.org

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